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ICMR invites EoI from companies for development, manufacturing of mAbs against Nipah virus

Shardul Nautiyal, Mumbai
Wednesday, November 5, 2025, 08:00 Hrs  [IST]

The Indian Council of Medical Research ((ICMR) has invited Expression of Interest (EoI) from the eligible organizations, companies and manufacturers for the development and manufacturing of monoclonal antibodies (mAbs) against Nipah viral disease. Last date of submission of the EoI is November 06, 2025.

Nipah virus has emerged as one of the most important zoonotic threats for India, with repeated outbreaks recorded since 2001.

ICMR is willing to collaborate with eligible organizations, companies, and manufacturers for the ‘Development and manufacturing of monoclonal antibodies against Nipah viral disease’. The company would be granted rights to undertake further development, manufacture, sell, and commercialize the technology/product ‘monoclonal antibodies against Nipah viral disease’ or undertake further R&D and commercialize the end product(s)/technology.

The ICMR-National Institute of Virology (ICMR-NIV), Pune, one of the constituent institutes of the ICMR, has expertise in various techniques, methods and information relating to aforesaid technology which could be used in R&D for development of mAbs against Nipah viral disease.

ICMR-NIV, Pune has already initiated R&D in this direction, with experimental work at an advanced stage. The ICMR-NIV has state-of-art laboratory infrastructure including BSL-3 & BSL-4 facility and the team possesses expertise in outbreak investigations, surveillance, virological and molecular characterization, vaccine candidate development through virus inactivation and molecular methods, and conducting preclinical trials in suitable animal models. The institute also specializes in laboratory testing to evaluate antibody and immune responses in clinical trials at different phases I, II & III.

The infrastructure and resources available at ICMR institutes, as indicated above at ICMR-NIV will be leveraged for joint R&D and preclinical studies.

The importance of having monoclonal antibody stocks ready for deployment in India cannot be overstated. Given the very high case fatality and absence of licensed vaccines, mAbs represent the only currently feasible biomedical countermeasure. Their greatest value lies in post-exposure prophylaxis for high-risk contacts such as healthcare workers exposed without adequate protection, family members in close contact, or laboratory personnel with accidental exposure. Administered early, they can potentially prevent disease onset, as demonstrated convincingly in animal models.

In addition, in patients presenting early during infection, mAbs may offer a therapeutic benefit by reducing viral load and limiting progression, thereby complementing supportive critical care. Maintaining ready access to such antibodies ensures that India can act swiftly during an outbreak. Pre-positioned stocks, streamlined regulatory and ethical approvals, and defined clinical protocols for prophylaxis and therapeutic use would allow immediate deployment without the delays that often occur when arrangements are attempted in the middle of an outbreak.

“This readiness, combined with continued strengthening of surveillance, infection control practices, and One Health investigations of bat reservoirs, will be critical for limiting the impact of Nipah virus outbreaks in the future. Looking ahead, India needs to build its own indigenous medical countermeasures against Nipah virus, particularly monoclonal antibodies. The intent is to take this forward through active collaboration with Indian industry partners for developing an indigenous monoclonal antibody platform, and manufacturing the stock will not only ensure timely and reliable access during outbreaks but also strengthen national preparedness for emerging viral threats,” according to an ICMR official.

Globally, research and development efforts are advancing but no licensed vaccine or antiviral is yet available. Several vaccine platforms are under investigation, including those supported by the Coalition for Epidemic Preparedness Innovations (CEPI), with one candidate having progressed to mid-stage human trials with India identified as a key site. Similarly, research at other international institutes are ongoing for developing vaccine candidates. However, these are still years away from licensure. On the therapeutic front, mAbs have emerged as the most promising option. The best studied candidate is m102.4, a fully human monoclonal antibody targeting the G glycoprotein of Nipah virus, which prevents viral entry by blocking its interaction with ephrin-B2/B3 receptors. m102.4 has shown strong protection in animal models and has been found safe in Phase 1 clinical trials.

Though definitive human efficacy data are lacking, the antibody has been used under compassionate protocols in Australia and was also made available to Kerala during recent outbreaks.

 

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